Specialist/Senior Specialist, Quality Assurance Operations
- Support batch disposition activities, including review of manufacturing batch records, QC test records, audit trails, and assembly of batch release package
- Serve as front-line QA for production areas, including partnering with QC, Manufacturing, and Facilities representatives to triage emerging issues, assess impact, and perform immediate mitigating actions
- Serve as QA partner on change controls, CAPAs, deviations, OOS, and non-conformances
- Identify and lead continuous improvement efforts
- Draft, revise, review, and/or approve controlled documents including Standard Operating Procedures
- Represent QA on cross-functional project teams and with external partners
- Promote Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP), as well as adherence to company regulations, policies, SOPs, and guidelines
- Identify and anticipate trends in quality issues; collaborate with leadership team to implement quality initiatives
- Bachelor's degree in life science or related discipline
- At least 5 years of experience in QA, QC or Manufacturing in an FDA-regulated industry, preferably biologic therapeutics
- Competence in GMP requirements
- Experience in Cell and Gene Therapy, CDMOs, Qualification/Validation; Veeva Quality Suite a plus
- Excellent verbal and written communication skills
- Strong interpersonal skills; able to interact effectively with a variety of internal and external personnel
- Proficient in MS Office applications
- The base annual compensation range for this role is $90,000.00 - $100,000 (Specialist level) and $100,000- $120,000 (Sr. Specialist); starting pay is determined by multiple job-related factors including a candidate’s skills, education and experience level, benchmark, and internal parity
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